JP4391221B2 - High frequency heating balloon catheter - Google Patents

Description

  The present invention relates to a high-frequency warming balloon catheter, and more particularly, to a high-frequency thermotherapy balloon catheter used for treating cardiovascular diseases.

There is a method for treating a lesion such as an arrhythmia source or arteriosclerosis by arranging a high-frequency energizing electrode inside a contractible balloon and radiating a high-frequency electric field from here to heat the tissue in contact with the balloon. Have been proposed (for example, Japanese Patent No. 2538375, Japanese Patent No. 2510428, Japanese Patent No. 2574119, US Pat. No. 6,491,710B2 by the present applicant).
JP 2003-102850 A

  In order to warm the tissue in contact with the balloon and treat it well, it is necessary to warm the tissue at as uniform a temperature as possible.

  The high-frequency energizing electrode disposed in the balloon cannot be disposed completely and uniformly in the balloon.

  In a conventional high-frequency warming balloon catheter, heat is generated unevenly due to the shape of the electrode disposed in the balloon, and heat convection is generated in the liquid in the balloon. There is a problem that temperature unevenness cannot be avoided, and the tissue in contact with the balloon cannot be heated to a uniform temperature.

  In order to solve the above problem, it has been proposed by the present applicant to stir the liquid in the balloon (Japanese Patent Laid-Open No. 2003-102850).

  However, if the liquid in the balloon is simply stirred, vortices are generated in the balloon not only in the vertical direction but also in the horizontal direction. On the other hand, the inventor of the present invention creates a temperature difference in the vertical direction in the balloon relative to the direction of gravity due to convection heat, and for this reason, the temperature of the upper part in the balloon is higher than the lower part due to convection heat, It was found that there was a problem that the temperature gap formed between the upper and lower sides could not be resolved reliably. The present invention is based on the knowledge of the inventors of the present invention as described above.

  Here, the temperature difference between the upper and lower sides formed between the upper and lower sides in the balloon refers to the downward direction of gravity in the state where the balloon catheter is used for therapeutic surgery etc., and the upward direction opposite to the direction of gravity. It is called direction.

  Therefore, the object of the present invention is to solve the above-mentioned problems of the prior art, reliably eliminate the temperature difference between the upper and lower sides due to convection heat in the balloon, and uniformly warm the tissue in contact with the balloon at the optimum temperature. An object of the present invention is to provide a high-frequency balloon catheter that safely heats an affected area.

  In order to achieve the above object, the high-frequency warming balloon catheter of the present invention includes a catheter shaft composed of an outer tube shaft and an inner tube shaft, and the outer tube shaft having a shape capable of contacting a target lesion in an expanded state. A balloon installed between the distal end of the inner cylindrical shaft and the vicinity of the distal end of the inner cylindrical shaft, a high-frequency energizing electrode disposed in or inside the balloon wall capable of transmitting high-frequency power, and the high-frequency energizing A lead wire electrically connected to the electrode for use, a temperature sensor capable of monitoring the temperature in the balloon, and upper and lower formed between the upper and lower sides in the balloon by convection heat in the fluid introduced into the balloon Vortex forming means for swirling the fluid in the balloon between the upper and lower sides to form a vortex so as to eliminate the inter-temperature difference.

  In addition, the vortex forming means propagates vibration to the fluid in the balloon via the fluid in the vibration propagation flow path formed between the inner circumference of the outer cylinder shaft and the outer circumference of the inner cylinder shaft. The vibration drive means and an end of the vibration propagation channel near the entrance of the balloon, and the vibration propagating from the vibration propagation channel into the balloon is deflected downward or upward in the balloon And vibration propagation deflecting means.

  The period of vibration by the vibration driving means includes a ejection period for ejecting the fluid in the balloon and a suction period for sucking the fluid in the balloon, and the ejection period is shorter than the suction period. The fluid ejection amount per unit time of the ejection period is greater than the fluid suction amount per unit time of the suction period, or the ejection period is longer than the suction period and per unit time of the ejection period The fluid ejection amount is smaller than the fluid suction amount per unit time of the suction period.

  The product of the ejection period and the fluid ejection amount is equal to the product of the suction period and the fluid suction amount.

  Further, the vibration propagation deflecting means has a pair of blades disposed in the vicinity of the inlet portion with the inner cylinder shaft interposed therebetween, and each of the pair of blades is connected to the balloon from the vibration propagation channel. It is arranged to be inclined so as to deflect the vibration propagating inward downward or upward in the balloon.

  The vibration propagation deflecting means includes a cylindrical portion having an opening at one end, a bottom portion at the other end, and a first hole portion and a second hole portion at a side portion, and the inner cylindrical shaft has a side surface of the cylindrical portion. The first hole part and the second hole part are vertically positioned and penetrated, and the cylinder part transmits vibration propagating from the vibration propagation flow path into the balloon downward or upward in the balloon. It is arranged to be inclined so as to be deflected in the direction.

  The vibration propagation deflecting means has a pair of one-way valves disposed in the vicinity of the inlet portion with the inner cylinder shaft sandwiched between the upper and lower sides, and one of the one-way valves pushes the fluid into the balloon. The other one-way valve opens and closes so as to suck fluid from the inside of the balloon.

  Further, the vibration propagation deflecting means has an extension pipe portion extending at the outer cylinder shaft and closed at a tip, and an opening is formed on either the lower side or the upper side of the extension pipe portion. It is characterized by being.

  In addition, the vibration propagation deflecting unit includes an extension pipe part extending from the outer cylinder shaft and closed at a tip, and a branch pipe extending from either the lower side or the upper side of the pipe part. It is characterized by.

  In addition, a mark for identifying a vertical position between the upper and lower sides of the balloon is provided.

  In addition, the mark is an X-ray opaque marker added to the catheter shaft.

  Further, the high-frequency energization electrode is spirally wound around the inner cylindrical shaft.

  The balloon is made of a resin that is antithrombotic, heat resistant, and elastic.

  According to the configuration of the present invention, the fluid in the balloon is swung between the upper and lower sides to eliminate the temperature difference between the upper and lower sides formed in the balloon by the convection heat in the fluid introduced into the balloon. The temperature difference between the upper and lower sides due to the convection heat in the balloon can be surely eliminated, and the tissue in contact with the balloon is uniformly heated at the optimum temperature to safely treat the affected area with heat. A radio frequency balloon catheter can be provided.

  As a result, if the balloon tissue contact temperature is maintained at 60 to 65 ° C. for 3 to 5 minutes, a transmural necrosis layer is safely formed in the contact area in three dimensions without ulceration due to thrombus formation or tissue evaporation. Can be formed. As a result, the source of arrhythmia can be cauterized. By performing isolation of the pulmonary vein opening and cauterization of the atrial muscle surrounding the pulmonary vein opening, it becomes possible to cure many atrial fibrillations originating from this site. In addition, since the right ventricular outflow tract can be cauterized on the circumference of the circumference, it is possible to cure ventricular tachycardia and ventricular fibrillation originating from this site.

  In addition, when an arteriosclerotic lesion tissue is heated at 43 to 45 ° C. for 20 minutes or more, it does not affect normal tissues such as endothelial cells, but induces apoptosis of inflammatory cells such as macrophages that are destabilizing factors, thereby causing arteriosclerosis. Lesions can be stabilized.

  It can also be applied to local hyperthermia for cancer. It is known that cancer cells are also suppressed or eliminated by heating at 43 to 45 ° C. for 20 minutes or more. The high-frequency balloon catheter according to the present invention can be effectively applied to bronchial cancer, bile duct cancer, liver cancer, prostate cancer, and the like.

  Embodiments of a pulmonary vein high-frequency warming balloon catheter according to the present invention will be described below with reference to the accompanying drawings.

First, a first embodiment which is a high-frequency warming balloon catheter for pulmonary vein electrical isolation for the treatment of atrial fibrillation will be described with reference to FIGS.
The balloon catheter has a shape that allows contact with a target lesion in an expanded state, and includes a catheter shaft 3 including an outer tube shaft 1 and an inner tube shaft 2, and a distal end portion of the outer tube shaft 1 and the inner tube shaft 2. High-frequency energization disposed in the wall of the balloon 4 or in the balloon 4 capable of transmitting high-frequency power between the balloon 4 disposed between the vicinity of the tip and the counter electrode 5 disposed on the body surface. Electrode 6, electrode lead 7 electrically connected to high-frequency energizing electrode 6, temperature sensor 8 capable of monitoring the temperature in balloon 4, temperature sensor lead 9, and introduction into balloon 4 Vortex forming means 12 for swirling the fluid in the balloon 4 between the upper and lower sides to form a vortex 10 so as to eliminate the temperature difference between the upper and lower sides formed in the upper and lower sides in the balloon 4 by convection heat in the generated fluid It has.

  Here, the fluid is a liquid such as physiological saline or a gas such as carbon dioxide. In addition, the vertical temperature difference between the upper and lower sides formed in the balloon 4 is such that the gravity direction is the downward direction and the opposite direction is the upward direction in the posture of the balloon 4 in the normal use state of the high-frequency heating balloon catheter. The temperature difference between the upper and lower sides formed by convection heat is formed up and down with respect to the direction of gravity.

  An X-ray opaque marker 30 is attached to one side of the outer periphery of the outer cylindrical shaft 1 as a mark for identifying the vertical position between the upper and lower sides where the temperature difference is caused by the convective heat of the balloon 4. By detecting the X-ray opaque marker 30 with the X-ray apparatus, the position and orientation of the vibration propagation deflecting means 20 of the vortex forming means 12 in the balloon 5 in the used state can be detected.

  The high-frequency energizing electrode 6 is spirally wound around the outer wall of the inner cylindrical shaft 2. As will be described later, the high-frequency energizing electrode 6 can be wound around the outer wall of the extension tube of the outer cylinder shaft 1. High frequency power is supplied to the high frequency energizing electrode 6 and the counter electrode plate 5 by the high frequency generator 13 through the electrode lead wire 7. The amount of high-frequency power supplied by the high-frequency generator 13 is controlled based on the temperature in the balloon 4 detected by the temperature sensor 8 so that the temperature in the balloon 4 becomes an appropriate temperature.

  The balloon 4 is made of a resin that is antithrombotic, heat resistant, and elastic. When cauterization is performed by crimping the high-frequency warming balloon catheter to the peripheral atrial muscle of the pulmonary vein opening (15 to 30 mm diameter), the balloon 4 having an expanded diameter of 20 to 40 mm is used.

  The balloon 4 is installed between the distal end portion of the inner cylindrical shaft 2 and the distal end portion of the outer cylindrical shaft 1 that are slidable with respect to each other, has a shape that closely contacts the atrial muscle around the pulmonary vein opening, and has an onion shape, for example.

  A guide wire 15 can be inserted into the inner cylinder shaft 2 and a chemical solution can be injected.

  The vortex forming means 12 propagates vibration to the fluid in the balloon 3 via the fluid in the vibration propagation channel 14 formed between the inner circumference 1a of the outer cylinder shaft 1 and the outer circumference 2a of the inner cylinder shaft 2. The vibration drive means 16 for driving and the balloon propagating channel 14 is provided in the vicinity of the balloon inlet 18 and the vibration propagating from the vibration propagating channel 14 into the balloon 4 is directed downward or upward in the balloon 4. Vibration propagation deflecting means 20 for deflecting in the direction.

  The vibration driving means 16 comprises a vibration generator having a period of about 1 second. As shown in FIGS. 12 and 13, the vibration period of the vibration driving means 16 is an ejection period 22 for ejecting the fluid in the balloon 4. And a suction period 23 for sucking the fluid in the balloon 4. As shown in FIG. 12, the vibration driving means 16 is configured so that the ejection period 22 is shorter than the suction period 23 and the fluid ejection amount 24 per unit time of the ejection period 22 is the fluid suction per unit time of the suction period 23. The product of the ejection period 22 and the fluid ejection quantity 24 and the product of the suction period 23 and the fluid suction quantity 25 are controlled to be substantially equal to each other. A symbol 26 indicates a time change of the volume of the balloon 4. As described above, the product of the ejection period 22 and the fluid ejection amount 24 and the product of the suction period 23 and the fluid suction amount 25 are controlled so as to be substantially equal, so that excessive fluid is accumulated in the balloon 4. The risk of bursting can be eliminated. Since the balloon 4 is made of an elastic material as described above, there is no problem even if the product of the ejection period 22 and the fluid ejection amount 24 and the product of the suction period 23 and the fluid suction amount 25 are slightly different. . 12A shows a time waveform, FIG. 12B shows the volume change of the balloon 4 during the ejection period, and FIG. 12C shows the volume change of the balloon 4 during the suction period.

  As shown in FIG. 12, the ejection period 22 is shorter than the suction period 23 and the fluid ejection amount 24 per unit time of the ejection period 22 is larger than the fluid suction amount 25 per unit time of the suction period 23. In addition, the vibration driving means 16 drives the asymmetric vibration waveform during the ejection period 22 and the suction period 23, whereby it is possible to transmit unidirectional rotational energy into the balloon 4.

  As shown in FIG. 13, the ejection period 22 is longer than the suction period 23, and the fluid ejection amount 24 per unit time of the ejection period 22 is smaller than the fluid suction amount 25 per unit time of the suction period 23. The product of the ejection period 22 and the fluid ejection amount 24 and the product of the suction period 23 and the fluid suction amount 25 can be controlled to be substantially equal. In this case, the direction of the vortex 10 is opposite to that shown in FIG.

  The vibration propagation deflecting means 20 in the vortex forming means 10 is driven by the vibration driving means 16 and the propagation direction of the vibration linearly propagated through the vibration propagation flow path 14 is either the downward direction or the upward direction in the balloon 4. To be deflected. The vibration propagation deflecting means 20 deflects the propagation of the vibration, and the vortex 10 swirling up and down is formed in the balloon 4, thereby eliminating the temperature difference between the upper and lower sides caused by the convection heat in the balloon 4.

  In the present embodiment, as shown in FIGS. 1 and 2, the vibration propagation deflecting means 20 in the vortex forming means 10 is a pair of elliptical shapes disposed in the vicinity of the inlet portion 18 with the inner cylinder shaft 2 interposed therebetween. It has vanes 32 and 34. The blades 32 and 34 are inclined to deflect the vibration propagating into the balloon 4 from the vibration propagation flow path 14 downward in the balloon 4, and project from the outer wall of the inner cylindrical shaft 2. . The blades 32 and 34 may be inclined so as to deflect the vibration propagating from the vibration propagation channel 14 into the balloon 4 in the upward direction in the balloon 4. A vortex 10 is formed in the opposite direction to that shown.

  The vibration driven by the vibration driving means 16 propagates through the fluid filled in the vibration propagation flow path 14, and the vibration propagation direction is deflected downward by the blade plates 32 and 34. Here, in principle, the fluid in the vibration propagation channel 14 does not move into the balloon 4, but the vibration propagates through the fluid in the vibration propagation channel 14. As shown in FIG. 12, the ejection period 22 is shorter than the suction period 23, and the fluid ejection amount 24 per unit time of the ejection period 22 is larger than the fluid suction amount 25 per unit time of the suction period 23. As described above, since the drive form in the ejection period 22 and the suction form in the suction period 23 are asymmetric, a vortex 10 mainly in one direction is formed in the balloon 4. As a result, the fluid in the balloon 4 is agitated, and the temperature difference between the upper and lower sides formed in the balloon 4 by convection heat can be eliminated.

  When energized between the high-frequency energizing electrode 6 in the balloon 4 and the counter electrode 5 on the body surface from the high-frequency generator 13, the tissue in contact with the balloon 4 and the balloon 4 is heated by capacitive coupling heating. When the temperature in the balloon 4 is monitored by the temperature sensor 8 and the high-frequency output is adjusted to keep the temperature in the balloon 4 at an optimum temperature, the cauterization part 41 of the left atrium 40 around the pulmonary vein opening that contacts the balloon 4 is obtained. It is heated and cauterized uniformly at the optimum temperature.

  FIG. 9 shows ablation (cauterization) of the affected area on the atrial side around the pulmonary vein opening using a high-frequency balloon catheter.

  The inside of the balloon 4 is repeatedly infused and sucked with physiological saline by the pump 46 from the inlet of the outer cylinder shaft 1 to release air. When inserting the catheter into the blood vessel, the inner cylinder shaft 2 is slid while the balloon 4 is deflated and pushed forward to the limit. At this time, the space between the distal end portion of the inner cylindrical shaft 1 and the distal end portion of the outer cylindrical shaft 2 is expanded, so that the diameter of the balloon 4 is minimized. In this state, the balloon 4 is inserted into the femoral vein using the guide wire 15 and the guiding sheath. When the catheter is operated to approach the pulmonary vein opening in the transatrial septum, the balloon 4 is infused with contrast medium and physiological saline while pulling the inner tube 2 and is 5 to 10 mm larger than the size of the pulmonary vein opening. The balloon 4 is further expanded and the balloon 4 is brought into contact with the target tissue in the left atrium 40 around the pulmonary vein opening. Further, the balloon catheter is rotated so that the radiopaque marker 30 for identifying the vertical direction of the balloon 4 is at a predetermined position. Thus, the inclination direction of the blade plates 32 and 34 is adjusted so that the vibration propagating from the vibration propagation channel 14 into the balloon 4 is deflected downward. That is, when it is assumed that the downward direction in FIG. 1 coincides with the direction of gravity, the balloon catheter is rotated so that the blades 32 and 34 are as shown in FIG.

  Actually, even if a balloon catheter is used with the vanes 32 and 34 as a target in the gravitational direction as shown in FIG. There is no inconvenience. Therefore, even if the balloon catheter is rotated so that the radiopaque marker 30 is located at a predetermined position, the generality in use of the balloon catheter is not lost.

The specific operation of the balloon catheter is performed as follows.
First, the vibration driving means 16 is connected to the outer cylinder shaft 1 with a connecting pipe, and the inside of the vibration propagation flow path 14 and the balloon 4 formed between the inner circumference 1a of the outer cylinder shaft 1 and the outer circumference 2a of the inner cylinder shaft 2 are connected. When the fluid is filled and the power is turned on, the vibration 36 propagates through the vibration propagation channel 14 and reaches the blades 32 and 34 disposed near the inlet 18 of the balloon 4. 34 is deflected downward by the balloon 4, and gives a vertical rotational force to the fluid in the balloon 4. When the vibration drive means 16 adjusts the vibration frequency and amplitude as shown in FIG. 12, a vortex 10 swirling up and down in the balloon 4 is formed, and the fluid in the balloon 4 is agitated. Next, when an ultrahigh frequency current (13.56 MHz) is passed through the high frequency energizing electrode 6 and the counter electrode plate 5 by the high frequency generator 13, capacitive coupling heating occurs, and the tissue (cautery) 41 that contacts the balloon 4 and the balloon 4. However, if the temperature distribution in the balloon is normal, there is a temperature difference between the upper and lower sides due to convection heat, but the temperature difference is eliminated by stirring by the vortex 10 swirling up and down. As a result, the tissue in contact with the balloon is uniformly heated.

  When the diameter of the pulmonary vein opening is 20 mm and a catheter with an expanded diameter of the balloon 4 of 25 mm and a length of the catheter shaft 3 of 70 cm is used, a single fluid is pumped out by the vibration driving means 16 at a frequency of 1.5 Hz. If an amount of vibration of about 2.5 cc is sent, the vortex 10 that swirls in the vertical direction with respect to the rotating fluid is formed in the balloon 4, and the upper and lower temperature difference due to convection heat is eliminated. When the high frequency output supplied by the high frequency generator 13 is about 100 to 150 W and the central temperature of the balloon 4 is kept at about 75 ° C., there is a temperature difference of 10 to 15 ° C. between the upper and lower sides when there is no stirring in the balloon 4. According to the present embodiment, it was confirmed that the temperature difference between the upper and lower sides can be kept within 2 ° C. when stirring with the vortex 10 formed in the balloon 4 is performed. As a result, the temperature difference between the central temperature of the balloon 4 and the contact tissue is about 10 ° C., but the tissue contact temperature can be 65 ° C. ± 2 ° C. Can be ablated circumferentially in a transmural manner. By electrically isolating the pulmonary vein 42 and cauterizing the left atrium 40 around the pulmonary vein opening, it becomes possible to appropriately treat atrial fibrillation originating from the pulmonary vein and the pulmonary vein opening.

Next, a second embodiment of the high-frequency warming balloon catheter of the present invention will be described with reference to FIGS. The description of the same parts as those in the first embodiment, such as the control of the fluid ejection amount 24 and the fluid suction amount 25 by the vibration driving means 16, is omitted.
In the second embodiment, the vibration propagation deflecting means 20 includes a cylindrical portion 50 in the vicinity of the inlet portion 18. The cylindrical part 50 has an opening 51 formed at one end and the other end closed at the bottom, and a first hole 52 and a second hole 53 are formed on the same side of the cylindrical part 50. . The inner cylinder shaft 2 penetrates the side surface of the cylinder part 50 densely, and the first hole part 52 and the second hole part 53 are located on the opposite side across the inner cylinder shaft. Further, as shown in FIG. 4, the cylinder portion 50 is held by a fitting plate 55 attached to the inner peripheral wall of the outer cylinder shaft 1. Since the inside of the outer cylinder shaft 1 is blocked by the fitting plate 55, the vibration propagation channel 14 and the inside of the balloon 4 are connected to the opening 51, the first hole 52, and the second hole 53 of the cylinder 50. Communicated only through. The cylindrical portion 50 is disposed so as to be inclined so as to deflect the vibration propagating from the vibration propagation channel 14 into the balloon 4 in the downward direction in the balloon 4 (in the case shown in FIG. 3).

  Also in the present embodiment, the balloon catheter is rotated so that the X-ray opaque marker 30 is located at a predetermined position, whereby the vibration propagating from the vibration propagation channel 14 into the balloon 4 is deflected downward. Thus, the inclination direction of the cylinder part 50 is adjusted. That is, when it is assumed that the downward direction in FIG. 3 coincides with the direction of gravity, the balloon catheter may be rotated so that the cylindrical portion 50 becomes as shown in FIG. Normally, the temperature distribution in the balloon has an upper and lower temperature difference due to convection heat, but is stirred by the swirling vortex 10 to eliminate the temperature difference and uniformly warm the tissue 41 in contact with the balloon. Is possible.

Next, with reference to FIG.5 and FIG.6, 3rd Embodiment of the high frequency heating balloon catheter of this invention is described. The description of the same parts as those in the first embodiment, such as the control of the fluid ejection amount 24 and the fluid suction amount 25 by the vibration driving means 16, is omitted.
In the third embodiment, the vibration propagation deflecting means 20 includes a pair of one-way valves 62 and 63 in the vicinity of the inlet 18. A holder 64 is attached to the outer peripheral portion of the inner cylindrical shaft 2 in the vicinity of the inlet 18, and the one-way valves 62 and 63 are attached between the holder 64 and the inner wall of the outer cylindrical shaft 1. The one-way valves 62 and 63 are arranged with the inner cylinder shaft 2 sandwiched up and down. The one-way valve 61 opens and closes to push the fluid into the balloon 4, and the one-way valve 62 opens and closes to suck the fluid from the balloon 4.

  Also in the present embodiment, the balloon catheter is rotated so that the radiopaque marker 30 is at a predetermined position so that the one-way valves 62 and 63 are in a vertical positional relationship. As a result, the vibration propagating from the vibration propagation flow path 14 into the balloon 4 is deflected downward via the one-way valve 61 at the bottom, forming a vortex 10, and the balloon 4 via the one-way valve 62. Propagates from inside to the vibration propagation channel 14. Also in this embodiment, if the temperature distribution in the balloon is normal, there is a vertical temperature difference due to convection heat, but the temperature difference is eliminated by stirring by the vortex 10 swirling up and down, and the tissue 41 in contact with the balloon Can be uniformly heated.

Next, a fourth embodiment of the high-frequency warming balloon catheter of the present invention will be described with reference to FIG. The description of the same parts as those in the first embodiment, such as the control of the fluid ejection amount 24 and the fluid suction amount 25 by the vibration driving means 16, is omitted.
In the high-frequency balloon catheter shown in FIG. 7, a large balloon 4 having an expanded diameter of 25 to 35 mm that can block the right ventricular outflow passage is installed between the distal ends of the inner tube shaft 2 and the outer tube shaft 1 that can slide with each other. Has been.

  In the fourth embodiment, the vibration propagation deflecting means 20 has an extension pipe portion 70 that extends from the outer cylinder shaft 1 and has a closed end, and an opening 71 is provided on the lower side surface of the extension pipe portion 70. Is formed. In the present embodiment, the pair of high-frequency energizing electrodes 6a and 6b are wound around the outer periphery of the extension tube portion 70, and the counter electrode plate 5 disposed on the body surface is not used. Each of the high-frequency energizing electrodes 6a and 6b is connected to the high-frequency generator 13 via electrode lead wires 7a and 7b passing through the outer cylinder shaft 1.

  Also in the present embodiment, the balloon catheter is rotated so that the X-ray opaque marker 30 is located at a predetermined position so that the opening 71 is at the lower position. As a result, the vibration propagating from the vibration propagation channel 14 into the balloon 4 is deflected downward through the lower opening 71 to form a vortex 10, and the vibration propagation from the balloon 4 through the opening 71 is performed. Propagates to the flow path 14. Also in this embodiment, if the temperature distribution in the balloon is normal, there is an upper and lower temperature difference due to convection heat, but this temperature difference is eliminated by stirring by the swirling vortex 10 up and down, and the tissue in contact with the balloon 4 It becomes possible to heat 41 uniformly.

  Next, an example in which the high-frequency balloon catheter shown in FIG. 7 is applied to the treatment of ventricular tachycardia and ventricular fibrillation originating from the right ventricular outflow tract will be described with reference to FIG.

  The inner cylinder shaft 2 is pushed out to extend the distance at which the balloon 4 is adhered between the outer cylinder shaft 1 and the inner cylinder shaft 2 (the distance between the balloon adhesion ends), and the balloon 4 is contracted. The guide wire 15 is inserted into the pulmonary artery percutaneously from the femoral vein. The high-frequency balloon catheter is inserted into the right ventricular outflow tract from the femoral vein along the guide wire 15, and the distal end of the pulmonary blood flow perfusion catheter 75 is inserted into the pulmonary artery from the opposite femoral vein. Turn the balloon catheter so that the radiopaque marker 30 is on the bottom. While shortening the distance between the balloon adhering ends while pulling out the inner cylinder shaft 2, the balloon is expanded with a contrast medium diluted with physiological saline, and the balloon wall is crimped to the right ventricular outflow passage. Next, the vibration generator 13 is operated, and the vibration is sent to the vibration propagation channel 14 while adjusting the frequency and amplitude. Vibration is propagated obliquely downward into the balloon 4 from the opening 71 formed on the lower side surface of the extension pipe 70, and the upper and lower vortices 10 are generated in the balloon 4. While monitoring the temperature inside the balloon 4, the high-frequency output is adjusted to keep the center temperature of the balloon 4 at about 75 ° C. At this time, cooling water is injected into the inner cylinder shaft 2 using the pump 46 to prevent overheating of the high-frequency energizing electrodes 6 and 6. The contact temperature of the balloon 4 is about 65 ° C., and the arrhythmia is cauterized uniformly and transmurally by energizing for 3 to 5 minutes to cure the arrhythmia.

Next, a fifth embodiment of the high-frequency warming balloon catheter of the present invention will be described with reference to FIG. The description of the same parts as those in the first embodiment, such as the control of the fluid ejection amount 24 and the fluid suction amount 25 by the vibration driving means 16, is omitted.
In the fifth embodiment, the vibration propagation deflecting means 20 has an extension pipe portion 80 extending from the outer cylinder shaft 1 and closed at the tip, and extending to the lower side surface of the extension pipe portion 80. 82 is formed. The distal end portion of the extension tube portion 80 protrudes from the distal end portion of the balloon 4, and the distal end portion of the balloon 4 is attached to the distal end portion side of the extension tube portion 80. The distal end portion of the inner cylindrical shaft 2 is coupled to the distal end portion of the extension pipe portion 80. In the present embodiment, the balloon 4 is not slidably mounted between the outer cylinder shaft 1 and the inner cylinder shaft 2, so that by sliding the outer cylinder shaft 1 and the inner cylinder shaft 2, Although the balloon 4 cannot be expanded and contracted, there is no problem when cauterizing the affected part of arteriosclerosis in the blood vessel.

  Also in the present embodiment, the balloon catheter is rotated so that the X-ray opaque marker 30 is at a predetermined position so that the branch tube 82 is at the lower position. As a result, the vibration propagating from the vibration propagation flow path 14 into the balloon 4 is deflected downward through the lower branch pipe 82 to form the vortex 10, and the vibration propagation from the balloon 4 through the branch pipe 82. Propagates to the flow path 14. Also in this embodiment, if the temperature distribution in the balloon is normal, there is an upper and lower temperature difference due to convection heat, but this temperature difference is eliminated by stirring by the vortex 10 swirling up and down, and the blood vessel in contact with the balloon 4 It becomes possible to uniformly warm the tissue 41 in which the arteriosclerosis has occurred.

  Next, an example in which the high-frequency balloon catheter shown in FIG. 8 is applied to the treatment of an arteriosclerotic lesion will be described with reference to FIG.

  FIG. 8 shows the shape of a high-frequency balloon catheter applied to the carotid artery. The diameter of the balloon 4 having an expanded diameter that can close the inner diameter of the carotid artery is 5 to 10 mm.

  The balloon 4 of the high-frequency balloon catheter inserted from the femoral artery with the balloon 4 contracted is brought into contact with the carotid artery lesion 41. When contrast medium-diluted physiological saline is injected from the outer cylinder shaft injection port via the liquid feeding path at this position, the balloon 4 is inflated and pressed against the stenosis. In this state, high-frequency energization is started while monitoring the temperature between the high-frequency energization electrode 6 in the balloon 4 and the counter electrode plate 5 at the back. At the same time, vibration is propagated to the vibration propagation channel 14 by the vibration driving means 16. As a result, the vibration propagating from the vibration propagation flow path 14 into the balloon 4 is deflected downward through the branch pipe 82 at the lower portion, and the vortex 10 swirling up and down is formed. By this vortex 10, the temperature difference between the upper and lower temperatures due to the convection heat formed in the balloon 4 can be eliminated, and the temperature in the balloon can be made uniform. In addition, the pump 46 is used to inject cooling water into the inner cylinder shaft 2 to prevent cauterization of the distal carotid artery. The contact temperature of the balloon 4 is about 43.5 ° C. When heated for about 20 minutes or more, inflammatory cells such as macrophages in the arteriosclerotic lesion contacting the balloon 4 undergo apoptosis and lead to stabilization of the arteriosclerotic lesion. When the stenosis is advanced, the stenosis is expanded by pressurizing the inside of the balloon 4 with high pressure. When the balloon 4 is not easily expanded, the cured stenosis is expanded when the temperature in the balloon 4 is raised to 50 to 60 ° C. and pressurized. Next, the balloon 4 is deflated and the high-frequency balloon catheter is removed.

It is a figure which shows 1st Embodiment of the high frequency heating balloon catheter of this invention, and shows the example which cauterizes the pulmonary vein periphery surrounding atrium side by a high frequency balloon catheter. Sectional drawing in AA of FIG. 1 which shows the vibration propagation deflection | deviation means of a balloon catheter. It is a figure which shows 2nd Embodiment of the high frequency heating balloon catheter of this invention, and shows the example which cauterizes the pulmonary vein periphery surrounding atrium side by a high frequency balloon catheter. Sectional drawing in BB of FIG. 3 which shows the vibration propagation deflection | deviation means of a balloon catheter. It is a figure which shows 3rd Embodiment of the high frequency heating balloon catheter of this invention, and shows the example which cauterizes the pulmonary vein periphery surrounding atrium side by a high frequency balloon catheter. Sectional drawing in CC of FIG. 5 which shows the vibration propagation deflection | deviation means of a balloon catheter. It is a figure which shows 4th Embodiment of the high frequency heating balloon catheter of this invention, and shows the example applied to the treatment of the ventricular tachycardia and ventricular fibrillation originating in the right ventricular outflow tract by the high frequency balloon catheter. It is a figure which shows 5th Embodiment of the high frequency heating balloon catheter of this invention, and shows the example which applied the high frequency balloon catheter to the treatment of an arteriosclerotic lesion. The figure which shows cauterizing the affected part of the pulmonary vein opening circumference | surroundings atrium side by the high frequency balloon catheter shown in FIG. 1 thru | or FIG. The figure which shows the example which applied the high frequency balloon catheter shown in FIG. 7 to the treatment of the ventricular tachycardia and ventricular fibrillation originating in the right ventricular outflow tract. The figure which shows the example which applied the high frequency balloon catheter shown in FIG. 8 to the treatment of an arteriosclerosis lesion. The time waveform of the vibration driven by the vibration driving means and the time change of the shape of the balloon are shown, (a) shows the time waveform, (b) shows the volume change of the balloon and the flow in the balloon during the ejection period, (C) shows the volume change of the balloon and the flow in the balloon during the suction period. The time waveform of the vibration driven by the vibration drive means and another example of the flow in the balloon are shown, (a) shows the time waveform, (b) shows the flow in the balloon during the suction period, (c) shows The flow in the balloon during the ejection period is shown.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Outer cylinder shaft 2 Inner cylinder shaft 3 Catheter shaft 4 Balloon 5 Counter electrode 6 Electrode for high frequency energization 7 Electrode lead wire 8 Temperature sensor 9 Temperature sensor lead wire 10 Vortex 12 Vortex formation means 14 Vibration propagation channel 16 Vibration drive means 18 Balloon inlet 20 Vibration propagation deflecting means 22 Ejection period 23 Suction period 24 Fluid ejection quantity 25 Fluid suction quantity 30 X-ray impermeable markers 32, 34 Wing plate 41 Ablation part (tissue)
46 Pump 50 Tube portion 52 First hole portion 53 Second hole portion 55 Fitting plates 62, 63 One-way valve 64 Holder 70 Extension pipe portion 71 Opening portion 80 Extension pipe portion 82 Branch pipe

Claims (11)

A catheter shaft comprising an outer tube shaft and an inner tube shaft;
A balloon installed between the distal end portion of the outer cylindrical shaft and the vicinity of the distal end portion of the inner cylindrical shaft having a shape capable of contacting the target lesion in an expanded state;
A high-frequency energization electrode disposed in the wall of the balloon or in the balloon capable of transmitting high-frequency power;
A lead wire electrically connected to the high-frequency energizing electrode;
A temperature sensor capable of monitoring the temperature in the balloon;
So as to eliminate the vertical interval temperature difference formed between the upper and lower in parallel up and down by convection heat in the introduced fluid in the gravity direction in the balloon in the balloon, said vertical fluid in the balloon and vortex forming means for forming a vortex swirled between the upper and lower in,
Equipped with a,
The vortex forming means includes
Vibration driving means for propagating vibration to the fluid in the balloon via the fluid in the vibration propagation flow path formed between the inner circumference of the outer cylinder shaft and the outer circumference of the inner cylinder shaft;
Vibration that is provided near the entrance of the balloon at the end of the vibration propagation channel and deflects the vibration propagating from the vibration propagation channel into the balloon downward or upward in the vertical direction in the balloon. Propagation deflection means;
With
A mark for identifying the position in the vertical direction between the upper and lower sides of the balloon is provided,
The high-frequency warming balloon catheter characterized in that the direction of deflection by the vibration propagation deflection means can be adjusted with respect to the direction of gravity by referring to the mark . The period of vibration by the vibration driving means includes a ejection period for ejecting the fluid in the balloon and a suction period for sucking the fluid in the balloon,
The ejection period is shorter than the suction period and the fluid ejection amount per unit time of the ejection period is greater than the fluid suction amount per unit time of the suction period, or the ejection period is the suction period The high-frequency warming balloon catheter according to claim 1, wherein the fluid ejection amount per unit time of the ejection period is smaller than the fluid suction amount per unit time of the suction period. . The high-frequency warming balloon catheter according to claim 2, wherein the product of the ejection period and the fluid ejection amount is equal to the product of the suction period and the fluid suction amount. The vibration propagation deflecting means has a pair of blades disposed in the vicinity of the inlet portion across the inner cylinder shaft, and each of the pair of blades is inserted into the balloon from the vibration propagation channel. The high-frequency warming balloon catheter according to claim 1, wherein the high-frequency warming balloon catheter is disposed so as to be inclined so as to deflect the propagating vibration downward or upward in the balloon. The vibration propagation deflecting means includes a cylindrical portion having an opening at one end, a bottom portion at the other end, and a first hole portion and a second hole portion at a side portion, and the inner cylindrical shaft has a side surface of the cylindrical portion at the first side. The first hole and the second hole are vertically positioned and penetrated, and the cylindrical part transmits vibration propagating from the vibration propagation channel into the balloon downward or upward in the balloon. The high-frequency warming balloon catheter according to claim 1, wherein the high-frequency warming balloon catheter is disposed so as to be deflected. The vibration propagation deflecting means has a pair of one-way valves disposed in the vicinity of the inlet portion with the inner cylindrical shaft sandwiched between the upper and lower sides, and the one-way valve opens and closes to push the fluid into the balloon. The high-frequency warming balloon catheter according to claim 1, wherein the other one-way valve opens and closes to suck fluid from the balloon. The vibration propagation deflecting means has an extension pipe part extending from the outer cylinder shaft and closed at a tip, and an opening is formed on either the lower side or the upper side of the extension pipe part. The high-frequency warming balloon catheter according to claim 1, wherein: The vibration propagation deflecting unit has an extension pipe part extending from the outer cylinder shaft and closed at a tip, and a branch pipe extending from either the lower side or the upper side of the pipe part. The high-frequency warming balloon catheter according to claim 1. The high-frequency warming balloon catheter according to claim 1, wherein the mark is an X-ray opaque marker added to the catheter shaft. The high-frequency warming balloon catheter according to claim 1, wherein the high-frequency energizing electrode is spirally wound around the inner cylindrical shaft. The high-frequency warming balloon catheter according to claim 1, wherein the balloon is made of a resin that is antithrombotic, heat resistant, and elastic.

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